Leaflet: information for the user

Tardyferon 80 mg prolonged-release tablets

Iron (in the form of ferrous sulfate anhydrous)

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1.What is Tardyferon and what is it used for

2.What you need to know before you start taking Tardyferon

3.How to take Tardyferon

4.Possible side effects

5.Storage of Tardyferon

6.Contents of the pack and additional information

This medication contains prolonged-action iron for the prevention and treatment of iron-deficiency anemias and iron-deficiency states.

It is used in children with a minimum weight of 28 kg and in adults.

Do not take Tardyferon:

• If you are allergic to ferrous sulfate or any of the other components of thismedication (listed in section 6).
• If you have too much iron in your body.
• If you have a type of anemia (insufficient number of red blood cells) that is not caused by a deficiency of iron or that causes an overload of iron (for example, thalassemia, refractory anemia, anemia caused by bone marrow deficiency).

Consult your doctor or pharmacist if you have any doubts about this medication.

Warnings and precautions

• If you are taking this medication for iron deficiency anemia, the underlying cause of this anemia should also be investigated to treat it.
• If the iron deficiency is associated with an inflammatory disorder, treatment with Tardyferon will not be effective.
• Consult your doctor or pharmacist before starting to takethis medicationsif you have difficulty swallowing.
• Based on literature data, gastrointestinal wall discoloration has been observed in elderly patients with renal insufficiency, diabetes (high blood sugar level) and/or hypertension (high blood pressure) who were receiving treatment for these diseases along with iron supplements for anemia. This gastrointestinal wall discoloration may complicate gastrointestinal surgery. In this case, if surgery is planned, it is recommended to inform the surgeon of the iron supplement intake (see section 4).
• If the medication is inhaled inadvertently (goes down the "wrong way"), it may enter your respiratory tract. If the medication comes into contact with the respiratory tract, it may cause damage such as necrosis (tissue death) or inflammation of the bronchi (the airways through which air passes through the lungs) or esophagus (the tube that connects the mouth to the stomach). These injuries may cause bronchi constriction. Associated symptoms may include: persistent cough, coughing up blood, and/or difficulty breathing, even if the aspiration occurred several days or months before these symptoms appear.
• If the medication has entered the respiratory tract and you present one or more of these symptoms, contact your doctor or the nearest emergency service as soon as possible for an evaluation by a specialist to ensure that there is no damage to the respiratory tract.
• Based on literature data, cases of open gastric ulcer and gastric hemorrhage have been reported in patients treated with iron tablets. In this case, it is recommended to switch to a liquid iron formulation (see Section 4).
• Due to the risk of mouth ulcers and tooth discoloration, tablets should not be chewed, crushed, or left in the mouth, but rather swallowed whole with water. If you cannot follow this instruction or have difficulty swallowing, contact your doctor.
• When taking Tardyferon, stools may become dark. This effect is harmless.

Children

This medicationshould not be administered to children weighing less than28 kg(between 9-10 years).

Other medications and Tardyferon

If you are taking the following medications, do not takethis medicationunless your doctor has prescribed it.

Indeed, some medications cannot be used at the same time, while others require specific changes (for example, in the timing of ingestion).

If you are taking medications that contain iron for injection, you should avoid taking Tardyferon.

If you are taking the following medications, you should separate their administration from Tardyferon by at least 2 hours:

• Certain antibiotics (ciclinas, fluoroquinolones, cefdinir)
• Medication to treat chronic urinary tract infection (acetohydroxamic acid)
• Medication to treat HIV infection (integrase inhibitors, bictegravir)
• Medications to treat osteoporosis or bone fragility (bifosfonates)
• Medications to treat joint diseases, Wilson's disease, or to prevent kidney stones (penicilamina, trientina)
• Medications to treat stomach acid: mineral gastrointestinals, charcoal, or antacids (aluminum, calcium, and magnesium salts)
• Medications to treat thyroid disease (thyroxine)
• Medications to treat Parkinson's disease(metildopa, levodopa, carbidopa, entacapona)
• Supplements and/or medications containing zinc or calcium

If you are taking colestiramina, Tardyferon should be taken 1 to 2 hours before or 4 to 6 hours after colestiramina administration.

If you are taking medications with ascorbic acid (vitamin C), iron absorption may be increased.

If you are taking medications with chloramphenicol, these may delay the response to iron treatment.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even if it is over-the-counter.

Tardyferon with food and drinks

Do not drink large amounts of tea, coffee, red wine as this may reduce iron absorption in your body.

It is not recommended to take this medication at the same time as cereals (oats, legumes, oilseeds), some proteins (eggs) or foods or drinks that contain calcium (cheese, milk, etc.). Leave a gap between the intake of iron salts and these foods (at least 2 hours).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to becomepregnant, consult your doctor or pharmacist before using this medication.

No specific studies have been conducted in pregnant women during the first trimester to evaluate the risk of congenital malformations. However, no congenital malformations have been reported in the literature or in post-marketing experience. During the second and third trimesters, there is a large amount of bibliographic data on pregnant women who do not indicate malformations or fetal/neonatal toxicity.

Consequently,this medicationcan be used during pregnancy if it is clinically necessary.

This medicationcan be used during breastfeeding.

Driving and operating machinery

The influence of the medication on the ability to drive and operate machinery is negligible or insignificant.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage:

- Mild iron-deficiency anemias, iron-deficient states, and increased iron needs: 1 tablet once a day, taken without chewing preferably 1 hour before or 3 hours after meals.

- Severe iron-deficiency anemias, with less than 8 to 9 g/dl of hemoglobin: 1 tablet in the morning and another in the afternoon, for 3 weeks, and then 1 tablet daily, taken without chewing, preferably 1 hour before or 3 hours after meals.

Pediatric population

This medication should not be administered to children weighing less than 28 kg (between 9-10 years).

Treatment duration

The duration of treatment will depend on the severity of iron deficiency, generally at least 3 months, treatment should continue and be prolonged as necessary to saturate iron reserves, guided by blood parameters of anemia correction (Hb, MCV) and restoration of iron reserves (serum ferritin, serum transferrin receptor, and transferrin saturation coefficient).

Administration form

Tablets are for oral use.

Swallow the tablets whole with water. Do not chew, crush, or leave the tablet in the mouth.

Tablets should be taken with a large glass of water before or during meals, depending on gastrointestinal tolerance (except for the specific foods mentioned in the "Taking Tardyferon with foods and beverages" section).

If you take more Tardyferon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose include signs of gastrointestinal irritation (characterized by abdominal pain, nausea, vomiting, diarrhea, and bleeding), which may evolve to symptoms of metabolic acidosis or cardiovascular shock (characterized by rapid or short breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, hypotension, and even seizures), followed by renal or hepatic insufficiency.

If you forgot to take Tardyferon

If you forgot to take a tablet, take it as soon as possible. However, if it is almost time for your next dose, wait for the next dose and then continue as usual.

Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Tardyferon

Do not stop taking the medication until the end of your treatment. Do not suspend treatment before, even if you feel better.

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 patients)

Difficulty defecating

Diarrhea

Abdominal distension

Abdominal pain

Black stools

Nausea

Less frequent (may affect up to 1 in 100 patients)

Swelling of the throat (laryngeal edema)

Abnormal stools

Indigestion (dyspepsia)

Vomiting

Stomach wall inflammation (gastritis)

Itching (pruritus)

Red skin rash (erythematous eruption)

Unknown frequency (cannot be estimated from available data)

Allergic reaction

Itchy rash (urticaria)

Lung cell or tissue death (pulmonary necrosis)*

Lung tissue inflammation (pulmonary granuloma)*

Respiratory tract narrowing (bronchostenosis)*

Throat ulceration*

Esophageal lesions*

Esophageal ulceration*

Dental discoloration**

Mouth ulcers**

Gastrointestinal tract wall discoloration (melanosis gastrointestinal) (see section 2)

Open gastric ulcer

Gastric bleeding (see section 2)

* All patients, but especially elderly patients and patients with swallowing difficulties may be at risk of developing a throat or esophageal ulcer. If the tablet passes into the respiratory tract, there may be a risk of bronchial ulceration and pulmonary granuloma (inflammation) that can cause bronchial narrowing.

** In the event of incorrect use, when the tablets are chewed, sucked, or left in the mouth.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Tardyferon

The active principle is iron 80 mg (in the form of ferrous sulfate anhydrous 247.25 mg).

The other components are:

• Core:maltodextrin, microcrystalline cellulose, triethyl citrate, talc, copolymer of dimethylaminoethyl methacrylate type B (Eudragit RS 30D), copolymer of dimethylaminoethyl methacrylate type A (Eudragit RL 30D)*, dibehenate of glycerol.

*see section 2 “Tardyferon contains”

• Coating:titanium dioxide (E171), sepifilm LP010**, yellow iron oxide (E172), red iron oxide (E172).

** Composition of Sepifilm LP010: hypromellose, microcrystalline cellulose, stearic acid.

Appearance of Tardyferon and contents of the packaging

Prolonged-release round red-orange colored tablets.

Blister packaging with 30 prolonged-release tablets.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

Ramón Trias Fargas, 7-11

08005 Barcelona

Spain

Responsible for manufacturing:

Pierre Fabre Medicament Production

Site PROGIPHARM

Rue du Lycée

45500 Gien

France

Last review date of this leaflet:06/2024

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/”